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Davol Inc.

Last updated September 17, 2026

Information

Country: US
Address: 160 New Boston St, WOBURN, MA, 01801
Website: bd.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)562-0027
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000120505
DUNS Number: 001191048

Catalogue (449)

Page 4 of 9

Device	Model / Reference	Registries	Class	Status
3dmax	0116320	FDA UDI	Class II	Active
Phasix	1190011	FDA UDI	Class II	Active
Visilex	0112900	FDA UDI	Class II	Unknown
Optifix	0113330	FDA UDI	Class II	Active
Monopolar High Frequency Cord Male to Female Connector	5601100	FDA UDI	Class II	Unknown
Ventrio	0010217	FDA UDI	Class II	Active
Simpulse	0067700	FDA UDI	Class II	Active
PerFix	0117080	FDA UDI	Class II	Active
Ventrio	5950040	FDA UDI	Class II	Active
Onflex	0115611	FDA UDI	Class II	Active
Hydro-Surg	5600100	FDA UDI	Class II	Unknown
Hydro-Surg	0026110	FDA UDI	Class II	Active
Simpulse VariCare	0067820	FDA UDI	Class II	Unknown
Onflex	0115610	FDA UDI	Class II	Active
3dmax	0117320	FDA UDI	Class II	Active
Bard	0113700	FDA UDI	Class II	Active
Reconix	0115230	FDA UDI	Class II	Unknown
Simpulse VariCare	0067880	FDA UDI	Class II	Unknown
Simpulse	0037630	FDA UDI	Class II	Unknown
Xenmatrix	1163045	FDA UDI	Class II	Active
X-Stream	5551000	FDA UDI	Class II	Active
Hydro-Surg	5103110	FDA UDI	Class II	Active
Phasix	1202530	FDA UDI	Class II	Active
Hydro-Surg	5600260	FDA UDI	Class II	Unknown
Bard	0112670	FDA UDI	Class II	Active
Xenmatrix	1161525	FDA UDI	Class II	Active
Bard	0113710	FDA UDI	Class II	Active
Hydro-Surg	5100025	FDA UDI	Class II	Active
Composix	0134114	FDA UDI	Class II	Active
Composix	0134790	FDA UDI	Class II	Active
Ventralight	5992025	FDA UDI	Class II	Active
Suretrans	8595000	FDA UDI	Class II	Active
3dmax	0117310	FDA UDI	Class II	Active
Xenmatrix	1151520	FDA UDI	Class II	Active
Phasix	1192020	FDA UDI	Class II	Active
PerFix	0112960	FDA UDI	Class II	Active
Simpulse	0067750	FDA UDI	Class II	Active
Hydro-Surg	5600002	FDA UDI	Class II	Unknown
Bard	0112710	FDA UDI	Class II	Active
Suretrans	8598000	FDA UDI	Class II	Unknown
Bard	0117012	FDA UDI	Class II	Active
Crurasoft	0116003	FDA UDI	Class II	Unknown
Hydro-Surg	5600380	FDA UDI	Class II	Active
Xenmatrix	1150610	FDA UDI	Class II	Active
Sorbafix	0113116	FDA UDI	Class II	Active
Composix	0134113	FDA UDI	Class II	Active
Xenmatrix	1161520	FDA UDI	Class II	Active
Phasix	1200015	FDA UDI	Class II	Active
Hydro-Surg	5539700	FDA UDI	Class II	Unknown
Kugel	0010101	FDA UDI	Class II	Active

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FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 25, 2026	Z-1896-2026	—	open, classified	Potential for product to contain foreign matter, confirmed to be inspect fragments.
Apr 25, 2023	Z-2242-2023	—	open, classified	Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Apr 25, 2023	Z-2241-2023	—	open, classified	Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Apr 25, 2023	Z-2244-2023	—	open, classified	Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Apr 25, 2023	Z-2243-2023	—	open, classified	Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Jun 27, 2022	Z-1457-2022	—	open, classified	The device may potentially cause a fire, leading to a safety risk.
Jun 7, 2022	Z-1305-2022	—	open, classified	The product is not able to provide irrigation.
Jun 7, 2022	Z-1304-2022	—	open, classified	The product is not able to provide irrigation.